MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN AEQUALIS FLEX STEM; PROSTHESIS SHOULDER JOINT METAL/POLYMER

Catalog Number UNK_WTB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Numbness (2415)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged numbness and weakness in her upper extremity, requiring an orthosis, could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by north shore university health system, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis flex revive shoulder system¿, which is associated with the stryker ¿aequalis flex revive shoulder ¿system.This report includes analysis of the clinical data that was collected on 49 patients, the cases in this study range from february 2019 to january 2022.During the review of this report, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced numbness and weakness in her upper extremity, requiring an orthosis.The report states: ¿(b)(6) woman who had fallen with a tibial fracture and proximal humeral fracture dislocation that was treated with a reverse total shoulder utilizing revive stem.Following the tsr, she underwent an open reduction and internal fixation (orif) of her tibia.She was found to have numbness and weakness in her upper extremity necessitating an orthosis to stabilize her wrist and hand.Subsequent electromyography (emg) identified it as a brachial plexopathy involving all trunks.The shoulder has been stable and functioning well.She has adequate motor strength for functioning in the upper extremity but some persistent numbness, mild weakness and mild persistent pain.¿.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by northshore university healthsystem, us.The title of this report is ¿a retrospective data collection of the treatment of shoulder joint replacement with the aequalis flex revive shoulder system¿, which is associated with the stryker ¿aequalis flex revive shoulder ¿system.This report includes analysis of the clinical data that was collected on 49 patients, the cases in this study range from february 2019 to january 2022.During the review of this report, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that one patient experienced numbness and weakness in her upper extremity, requiring an orthosis.The report states: ¿59 y.O.Woman who had fallen with a tibial fracture and proximal humeral fracture dislocation that was treated with a reverse total shoulder utilizing revive stem.Following the tsr, she underwent an open reduction and internal fixation (orif) of her tibia.She was found to have numbness and weakness in her upper extremity necessitating an orthosis to stabilize her wrist and hand.Subsequent electromyography (emg) identified it as a brachial plexopathy involving all trunks.The shoulder has been stable and functioning well.She has adequate motor strength for functioning in the upper extremity but some persistent numbness, mild weakness and mild persistent pain.¿.

Manufacturer Narrative

Correction: h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.

• Brand Name: UNKNOWN AEQUALIS FLEX STEM
• Type of Device: PROSTHESIS SHOULDER JOINT METAL/POLYMER
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14337270
• MDR Text Key: 291225116
• Report Number: 3004983210-2022-00056
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female